June 2021 FDA Recall Zyprexa by Eli Lilly & Company
D-0720-2021 - cGMP deviations
This Class II drug recall was voluntarily initiated by Eli Lilly & Company on June 29, 2021 for the product Zyprexa. The FDA reported the reason for recall as cgmp deviations. The product was distributed in OH, MS, IN and the recall is currently terminated.
Recall Number: D-0720-2021
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
06-29-2021
08-18-2021
36,540 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eli Lilly & Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OH, MS, IN
07-29-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
Batch or Lot Expiration Information
Lot# 197
